FINEFRA KIDS TOOTH- silicon dioxide, alcloxa paste, dentifrice

Finefra Kids Tooth by

Drug Labeling and Warnings

Finefra Kids Tooth by is a Otc medication manufactured, distributed, or labeled by Jewoo Medical Co,.Ltd, Korea Life Science Co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Silica 13.00%, Alcloxa 0.16%

INACTIVE INGREDIENT

Inactive ingredients:

Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, Stevioside, Flavor, Cellulose Gum, Xylitol, Charcoal Powder, Glycyrrhiza Glabra (Licorice) Root Extract, Aloe Barbadensis Leaf Extract, Gentiana Lutea Root Extract, Lavandula Angustifolia (Lavender) Flower Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Chitosan, Chamomilla Recutita (Matricaria) Flower Extract, Propolis Extract, Scutellaria Baicalensis Root Extract, Mika, Commiphora Myrrha Oil, Krameria Triandra Root Extract, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil

PURPOSE

Purpose: Anticavity

WARNINGS

Warnings:

If you accidentally swallow more than used for brushing, Seek professional help or contact a poison control center immediately.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

Aids in the prevention of cavities, plaque, and gingivitis.

Directions

Directions:

children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FINEFRA KIDS TOOTH 
silicon dioxide, alcloxa paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69653-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	9.10 g  in 70 g
ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z)	ALCLOXA	0.11 g  in 70 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69653-120-02	1 in 1 CARTON	12/01/2019
1	NDC: 69653-120-01	70 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2019

Labeler - Jewoo Medical Co,.Ltd (689512541)

Registrant - Jewoo Medical Co,.Ltd (689512541)

Establishment
Name	Address	ID/FEI	Business Operations
Korea Life Science Co.,ltd		694914835	manufacture(69653-120)